A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) or Gastric/Gastroesophageal Junction Cancer (GC/GEJC)

  • STATUS
    Recruiting
  • End date
    Oct 25, 2022
  • participants needed
    104
  • sponsor
    BeiGene
Updated on 25 January 2021
cancer
metastatic hepatocellular carcinoma

Summary

The purpose of this study is to evaluate the safety,tolerability, pharmacokinetics and preliminary antitumor activity of sitravatinib as monotherapy and in combination with tislelizumab in participants with unresectable locally advanced or metastatic hepatocellular carcinoma or gastric/gastroesophageal junction cancer.

Description

This is an open-label, multicenter Phase 1/2 clinical study for participants with histologically or cytologically confirmed unresectable locally advanced or metastatic HCC or G/GEJ cancer. All participants will receive study treatment (s) until progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. This study consists of the following phases.

Phase 1 (Dose escalation for sitravatinib as monotherapy and in combination with tislelizumab): Two dose levels of sitravatinib as monotherapy, 80 mg once daily and 120 mg once daily, will be evaluated in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer. A modified 3+3 design will be used in the dose escalation. Approximately 6 to 12 DLT evaluable participants will be treated with sitravatinib as monotherapy. The combination dose escalation of sitravatinib (80 mg once daily and 120 mg once daily; modified 3+3 design) with tislelizumab (200 mg every 3 weeks, in both cohorts) will be evaluated in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer. Approximately 12 to 24 DLT evaluable participants will be treated with sitravatinib in combination with tislelizumab.

Phase 2 (Dose expansion for sitravatinib as monotherapy and in combination with tislelizumab): Approximately 20 participants will be enrolled in each cohort. There will be a total of 4 cohorts in the study.

  • Cohort A: Anti-PD-1/PD-L1 Antibody Nave or Refractory/Resistant HCC
  • Cohort B: Anti-PD-1/PD-L1 antibody naive HCC
  • Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant HCC
  • Cohort D: Anti-PD-1/PD-L1 antibody naive G/GEJ cancer

Details
Condition HEPATOCELLULAR CARCINOMA, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, Gastric/Gastroesophageal Junction Cancer, liver cell carcinoma, Gastric/Gastroesophageal Junction Cancer
Treatment Sitravatinib, Sitravatinib plus Tislelizumab, Sitravatinib and tislelizumab
Clinical Study IdentifierNCT03941873
SponsorBeiGene
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic HCC/GC/GEJC
Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
Age 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place)
Adequate organ function
Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and 120 days after the last dose of study drug(s), and have a negative serum pregnancy test 7 days of first dose of study drug(s)
Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for 120 days after the last dose of study drug(s)
Failed current standard-of-care treatment, or standard-of-care treatment is considered not appropriate at present

Exclusion Criteria

Active leptomeningeal disease or uncontrolled brain metastasis
Active autoimmune diseases or history of autoimmune diseases that may relapse
Any active malignancy 2 years
History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc
Severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)
Known history of human immunodeficiency virus (HIV) infection
Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers
Any major surgical procedure requiring general anesthesia 28 days before the first dose of study drug(s)
Prior allogeneic stem cell transplantation or organ transplantation
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring
Any systemic chemotherapy within 28 days of the first dose of study drug(s) or hormone therapy, targeted therapy, or any investigational therapies Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)
Inability to swallow capsules or disease significantly affecting gastrointestinal function
Pregnant or breastfeeding woman
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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